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ottled brown Target over heart Utah, USA has a problem. Citizens cannot obtain drugs required for capital punishment by lethal injection. The alternative firing squad (five anonymous police markspersons) fire four live bullets and one blank onto a target pinned over the heart. Lethal injections contain chemicals, commonplace in industrial pharmacy but so elderly that they have grown whiskers. Sodium thiopental was first used clinically in 1934; pentobarbitone in 1930; curare, akin to the potentially lethal muscle relaxant pancuronium, in 1948. Humphry Davy discovered potassium chloride in 1817. Apparently some injections were “botched”. Observers noted the condemned took hours to die. An American manufacturer, such as Hospira for thiopental, will not supply such medicaments to prisons. Moreover, the EU, under “torture regulations” (Council Regulation (EC) No 1236/2005) bans export of certain drugs. That is despite lethal injection being deemed not a medical procedure. That by-passes doctors’ concerns. At that point, Brown’s nose twitched. I felt like a small pig detecting a whiff of mouth-watering truffle underneath forest litter. What brutalising and barbaric nonsense and delicious ironies did my snout detect? Way to go My starting reflection was that, had I been a particularly undesirable citizen of Utah condemned to death, my preferred exit would be by efficiently-administered injection. I remember experiencing intravenous barbiturates as precludes to gaseous general anaesthesia. I drifted into sleep. If longer than desired, there could be worse ways to exit. It seems preferable to the Gaelic Guillotine (fraction of a second), hanging (second or two) or electrocution (dozens of seconds). Maybe that exposes my bias because medicines have been my life. In salad days, dispensing wonderful-smelling Brompton cocktail with heroin, honey, brandy, chloroform water and so forth, I reflected that, if ever I required it, I hoped some pharmacist would be available to compound. That would be more human than the clinically efficient MST and Oramorph – and more tasty. I then wondered whether I would be willing to certify a batch of lethal injections fit for release onto the EU market, as a qualified person; Netherlands citizens use similar cocktails for euthanasia. I have left that fray but, were I still involved, my answer would probably be “Yes”. Indeed, I would strain every sinew to ensure that it was made, as our American cousins might say, “real good”. Medicine safety Those reflections deposited me within the Medicines and Healthcare Products Regulatory Agency (MHRA) website. That informed “what you need to know” about medicine safety. Before licensing, medicines should be “thoroughly trialled on thousands of people”, the “advantages” must “outweigh the disadvantages of taking the medicine” and, for the people taking the medicine (condemned criminals), “do the most good for the least harm”. I sensed a mismatch between those aims and the prisons in Utah containing human beings whom some staff labelled as “monsters”. For example, I am unaware of thousands of clinical trials testing “superdoses” of lethal agents resulting in death. In fairness, package inserts and label exclude that outcome. Scrutiny of the MHRA website exposed it as glaringly anthropocentric. Humans (not say, salmon; they require medicines, also: I have made them) are its taken-for-granted reference species. It is fascinating that octopi are deemed so intelligent that the UK considers them honorary vertebrates for the purposes of animal cruelty laws. Presently, I am ingesting for bronchitis – thankful to be a patient in the rich West – clarithromycin. Hopefully, that is “harmless” to my mammalian cells but will kick-the-ass of Haemophilus influenzae, Streptococcus pneumoniae and pyogenes and any other unfriendly interlopers. I end with a final twitch in viewpoint. Most of humankind accepts the scientific evidence base that capital punishment is ineffective. Malcolm E Brown 24 european INDUSTRIAL <strong>PHARMACY</strong> September 2015 • Issue 26
news from the EIPG European Medicines Agency (a) EIPG comments on the Concept Paper for Guideline on Topical Products have been submitted to the European Medicines Agency. For a copy of the comments, see the EIPG website under “News” from the Bureau. (b) EIPG comments on the Draft Guideline on the Chemistry of Active Substances are being consolidated by Georgina Gal (Hungary) and Marianne Anderson (Sweden). European Commission A draft Commission Delegated Regulation has been published on the Unique Identifier and includes the details of the rules for the safety features appearing on the outer packaging of medicines. It will apply 3 years from publication of the final text. The 34 pages of main document and 5 pages of annexes can be found at http://ec.europa.eu/growth/toolsdatabases/tbt/en/search/?tbtaction=se arch.detail&num=306&Country_ID=E U&dspLang=EN&BASDATEDEB=&b asdatedeb=&basdatefin=&baspays= EU&basnotifnum=306&basnotifnum2 =306&bastypepays=EU&baskeywords If any reader wishes to submit comments on the draft, they should be sent to Piero Iamartino (pieroiamartino@gmail.com). News from the European Parliament A new section under “News” has been added to the EIPG website called "European Parliament Pharma Watch". It collects questions and answers, statements, etc at the European Parliament on matters relating to the pharmaceutical industry. See http://eipg.eu/eurparlpharm/ EIPG awards Fellow of EIPG The purpose of this award is to recognise individuals who have exhibited strong leadership internationally, have distinguished themselves in the pharmaceutical sciences and/or practice of industrial pharmacy, who have contributed to the advancement of pharmaceutical sciences and/or practice of industrial pharmacy, and who have served the EIPG. Nominations for next year’s award should be submitted by any EIPG Full Member Association not later than 1 January 2016. EIPG Emerging Industrial Pharmacist Award The purpose of this award is to recognise significant intellectual contributions by emerging industrial pharmacists within EIPG that promote state of the art in industrial pharmacy and the pharmaceutical sciences. Nominations for the award may be submitted by any EIPG Full Member not later than 1 January of the year in which the award is to be made. At the time of nomination, the nominee should be a person who is within 10 years of having started a career in industrial pharmacy. Education A new publication on the Phar-In project has been published: A European competence framework for industrial pharmacy practice in biotechnology. Pharmacy 2015;3(3):101–128; doi:10.3390/pharmacy3030101 A new course on Personalised Medicine prepared by Drs Claire Thomson and Felicity Sartain is available on the PharmaConsult website. This can be found at http://www.pharmaconsultglobal.co m/course_detail.html?id=31 MOGLYNET Project EIPG has been invited to join as a partner in an important European educational project addressed to master students willing to achieve a doctorate level degree. This project, called MOGLYNET, involves five European universities (Milan, Antwerp, Leiden, Aberdeen and Barcelona) and the participation of a few industrial partners and professional association partners, who have offered their support in terms of consultancy, training and assistance to the development of the research and educational activities of 12 doctorate candidates. In particular, EIPG will be involved in the recruitment phase of students for this project and in the assistance for setting up appropriate training courses promoting an integrated knowledge between university research and pharmaceutical industrial expectations. Anni Svala, EIPG Vice-President Education and Careers and Finnish delegate, is in charge of representing EIPG in this project. European Pharmaceutical Students Association Two further successful webinars have been held, each with an audience of 50 participants. The speaker on Pharmacovigilance Audits and Quality Systems was Susanna Heinonen, PV manager, Algol Pharmaceuticals, and the Importance of Continuing Professional Development was presented by Claire Johnson, EBI, LifeTrain. Jane Nicholson, Executive Director EIPG jane@nicholj.plus.com european INDUSTRIAL <strong>PHARMACY</strong> September 2015 • Issue 26 25
Page 1 and 2: european INDUSTRIAL PHARMACY featur
Page 3 and 4: editorial The journey and the goal
Page 5 and 6: FIRST-IN-CLASS INNOVATION IN THE PI
Page 7 and 8: l i FIRST-IN-CLASS INNOVATION IN TH
Page 9 and 10: CHILD RESISTANCE IN PHARMACEUTICAL
Page 11 and 12: GETTING TO HIGHER QUALITY PROCESSES
Page 13 and 14: GETTING TO HIGHER QUALITY PROCESSES
Page 15 and 16: IN SILICO CLINICAL TRIALS: DREAM OR
Page 17 and 18: IN SILICO CLINICAL TRIALS: DREAM OR
Page 19 and 20: A unique and comprehensive guide to
Page 21 and 22: 88 Global Opportunity Healthcare 20
Page 23: REGULATORY REVIEW continued death o

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